Drug recall
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw…
FDA recall event 79067 · Class II · OrthoPediatrics Corp
Key facts
| Event ID | 79067 |
|---|---|
| Recall numbers | Z-0597-2018 |
| Recalling firm | OrthoPediatrics Corp |
| Product type | Devices |
| Products | Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. |
| Initiation date | Aug 3, 2017 |
| Report date | Feb 21, 2018 |
| Termination date | May 8, 2019 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 3006460162 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: